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Completed Phase 3 Interventional Results available

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

ClinicalTrials.gov ID: NCT01243424

Public ClinicalTrials.gov record NCT01243424. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

Study identification

NCT ID
NCT01243424
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
6,103 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 11, 2010 (Actual)
Primary completion
Aug 21, 2018 (Actual)
Completion
Aug 21, 2018 (Actual)
Last update posted
Jan 7, 2020

2010 – 2018

United States locations

U.S. sites
177
U.S. states
36
U.S. cities
142
Facility City State ZIP Site status
North Alabama Research Center, LLC Athens Alabama 35611 —
Alabama Internal Medicine, PC Birmingham Alabama 35235 —
Cahaba Research, Inc. Birmingham Alabama 35242 —
Internal Medicine Center, LLC Mobile Alabama 36608 —
Diagnostic and Medical Clinic Mobile Alabama 36695 —
Extended Arm Physicians, Inc. Montgomery Alabama 36106 —
Office of Dr. Terence T. Hart MD Tuscumbia Alabama 35674 —
Advanced Clinical Research Pell City Alaska 35128 —
Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC Mesa Arizona 85203 —
Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC Mesa Arizona 85213 —
Genova Clinical Research Tucson Arizona 85704 —
Quality of Life Medical & Research Center Tucson Arizona 85712 —
Northeast Arkansas Baptist Clinic Jonesboro Arkansas 72404 —
Medical Investigations, Inc Little Rock Arkansas 72205 —
Aureus Research, Inc Little Rock Arkansas 72211 —
Desert Oasis Healthcare Bermuda Dunes California 92203 —
Edinger Medical Group and Research Center Fountain Valley California 92708 —
Clinical Trials of St. Jude Heritage Med. Group Fullerton California 92835 —
Long Beach Center for Clinical Research Long Beach California 90807 —
Office of Dr. Richard S. Cherlin Los Gatos California 95032 —
Providence Clinical Research North Hollywood California 91606 —
Chaparral Medical Group, Inc Pomona California 91767 —
ARI Clinical Trials, Inc Redondo Beach California 90277 —
San Diego Sports Medicine and Family Health Center San Diego California 92120 —
West Coast Research, LLC San Ramon California 94582 —
University of California Los Angeles Sylmar California 91342 —
Metabolic Institute of America Tarzana California 91356 —
Matrix Research Institute Tustin California 92780 —
Orange County Research Center Tustin California 92780 —
Westlake Medical Research Westlake Village California 91361 —
Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC Colorado Springs Colorado 80909 —
Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC Colorado Springs Colorado 80920 —
East Coast Medical Associates Boca Raton Florida 33433 —
Todd Kazdan, DO Family Practice Davie Florida 33314 —
Century Clinical Research, Inc Daytona Beach Florida 32117 —
Doral Research Center Doral Florida 33172 —
Riverside Clinical Research Edgewater Florida 32132 —
Alan Graff, MD, PA Fort Lauderdale Florida 33309 —
M & O Clinical Research, LLC Fort Lauderdale Florida 33316 —
Eastern Research Hialeah Florida 33013 —
Research in Miami Inc Hialeah Florida 33013 —
Jacksonville Impotence Treatment Center Jacksonville Florida 32223 —
East Coast Institute for Research, LLC Jacksonville Florida 32258 —
Care Partners Clinical Research LLC Jacksonville Florida 32277 —
Precision Clinical Research, LLC Lauderdale Lakes Florida 33319 —
Veritas Research Corporation Miami Florida 33126 —
APF Research, LLC Miami Florida 33134 —
Swiss Medical Research Miami Florida 33135 —
University of Miami Miami Florida 33136 —
South Miami Clinical Research Miami Florida 33143 —
Well Pharma Medical Research Miami Florida 33143 —
Advanced Pharma CR, LLC Miami Florida 33147 —
AppleMed Research Group, LLC Miami Florida 33155 —
Kendall South Medical Center, Inc Miami Florida 33185 —
Suncoast Clinical Research, Inc. New Port Richey Florida 34652 —
Advanced Research Institute, Inc New Port Richey Florida 34653 —
Sunshine Research Center Opa-locka Florida 33054 —
Diabetes and Endocrine Center of Orlando Orlando Florida 32803 —
Suncoast Clinical Research Palm Harbor Florida 34684 —
Misal Khan, MD FRCS, ED, PA Panama City Florida 32401 —
Iconic Clinical Trials Pembroke Pines Florida 33024 —
Gulf Region Clinical Research Institute Pensacola Florida 32514 —
St. John's Center for Clinical Research Ponte Vedra Beach Florida 32081 —
Metabolic Research Institute West Palm Beach Florida 33401 —
PMI Health Research Group Atlanta Georgia 30312 —
Atlanta Diabetes Associates Atlanta Georgia 30318 —
Albert F. Johary MD, PC Dunwoody Georgia 30338 —
Georgia Clinical Research, LLC Snellville Georgia 30078 —
Hayden Lake Family Physicians Hayden Lake Idaho 83835 —
Boise Kidney and Hypertension Institute Meridian Idaho 83642 —
Suburban Clinical Research Bolingbrook Illinois 60490 —
Cedar-Crosse Research Center Chicago Illinois 60607 —
John H. Stroger Jr. Hospital of Cook Country Chicago Illinois 60612 —
Apex Medical Research Chicago Illinois 60616 —
Pharmakon Inc Evergreen Park Illinois 60805 —
American Health Network Avon Indiana 46123 —
Investigators Research Group, LLC Brownsburg Indiana 46112 —
American Health Network of Indiana, LLC Franklin Indiana 46131 —
Mapleton Medical Center Indianapolis Indiana 46205 —
American Health Network, LLC Indianapolis Indiana 46254 —
McKinley Research, LLC Mishawaka Indiana 46545 —
American Health Network of Indiana, LLC Muncie Indiana 47304 —
MCM Clinical Research, LLC Florence Kentucky 41042 —
Kentucky Diabetes Endocrinology Center Lexington Kentucky 40503 —
Four Rivers Clinical Research, Inc Paducah Kentucky 42003 —
Crescent City Clinical Research Metairie Louisiana 70006 —
Acadia Clinical Research, LLC Bangor Maine 04401 —
Office of Dr. Stephen R. Smith, MD Baltimore Maryland 21234 —
Endocrine and Metabolic Consultants Rockville Maryland 20852 —
Tristan Medical Enterprises, PC dba Regeneris North Attleboro Massachusetts 02760 —
ClinSite, LLC Canton Michigan 48187 —
Apex Medical Research, AMR Inc Flint Michigan 48504 —
Westside Family Medical Center, PC Kalamazoo Michigan 49009 —
Tri City Medical Centers, PC Livonia Michigan 48152 —
KMED Research Saint Clair Shores Michigan 48081 —
Tri-County Research, Inc Sterling Heights Michigan 48310 —
Medical Research Associates Traverse City Michigan 49684 —
Oakland Medical Research Center Troy Michigan 48085 —
Park Nicollet Institute Minneapolis Minnesota 55416 —
The Center for Clinical Trials, Inc. Biloxi Mississippi 39531 —
Mercy Health Research St Louis Missouri 63141 —
Quality Clinical Research Omaha Nebraska 68114 —
Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC Henderson Nevada 89052 —
Clinical Research of South Nevada Las Vegas Nevada 89121 —
Palm Medical Research Center Las Vegas Nevada 89148 —
Atco Medical Associates, PC Atco New Jersey 08004 —
Summit Medical Group Clifton New Jersey 07012 —
USMA Clinical Research Elizabeth New Jersey 07201 —
Central Jersey Medical Research Elizabeth New Jersey 07202 —
Albany Medical Center / Albany Medical College Albany New York 12206 —
Endocrine Associates of Long Island, PC Smithtown New York 11787 —
Southgate Medical Group/ Southgate Medical Park West Seneca New York 14224 —
OnSite Clinical Solutions, LLC Asheville North Carolina 28801 —
Kernodle Clinic West Burlington North Carolina 27215 —
The University of North Carolina at Chapel Hill Chapel Hill North Carolina 27517 —
Internal Medicine Research Charlotte North Carolina 28204 —
Gaffney Health Services Charlotte North Carolina 28205 —
Durham Internal Medicine Associates Durham North Carolina 27704 —
Sentara Family Medicine Elizabeth City North Carolina 27909 —
PMG Research of Raleigh, LLC Raleigh North Carolina 27609 —
Carolina Research Center, Inc Shelby North Carolina 28150 —
Piedmont Healthcare Statesville North Carolina 28625 —
PMG Research of Wilmington, LLC Wilmington North Carolina 28401 —
Community Health Care of Manchester Akron Ohio 44319 —
Community Medical Associates, LLC Austintown Ohio 44515 —
Harrison Community Research Center Cadiz Ohio 43907 —
Medical Frontiers, LLC Carlisle Ohio 45005 —
Genoa Medical Center Genoa Ohio 43430 —
Office of Dr. Craig S. Thompson, MD, LLC Marion Ohio 43302 —
RAS Health Limited Marion Ohio 43302 —
Advanced Medical Research, LLC Maumee Ohio 43537 —
Pharmacotherapy Research Associates, Inc Zanesville Ohio 43701 —
Infinity Research Group, LLC Oklahoma City Oklahoma 73103 —
Castlerock Clinical Research Consultants, LLC Tulsa Oklahoma 74136 —
Oregon Medical Group Eugene Oregon 97401 —
Harleysville Medical Associates Harleysville Pennsylvania 19438 —
Detweiler Family Medicine & Associates, PC Lansdale Pennsylvania 19446 —
Temple University School of Medicine Philadelphia Pennsylvania 19140 —
Warminster Medical Associates, PC Warminster Pennsylvania 18974 —
New England Center for Clinical Research, Inc Cranston Rhode Island 02920 —
Hartwell Research Group, LLC Anderson South Carolina 29621 —
Paris View Family Practice Greenville South Carolina 29601 —
Mountain View Clinical Research Greer South Carolina 29651 —
South Carolina Nephrology and Hypertension Center, Inc Orangeburg South Carolina 29118 —
Carolina Diabetes & Kidney Center Sumter South Carolina 29150 —
PMG Research of Bristol Bristol Tennessee 37620 —
University Diabetes and Endocrine Consultants Chattanooga Tennessee 37411 —
University of Tennessee Memphis Tennessee 38163 —
Trinity Clinical Research, LLC Tullahoma Tennessee 37388 —
KRK Medical Research Arlington Texas 76012 —
Austin Center for Clinical Research Austin Texas 78758 —
Punzi Medical Center Carrollton Texas 75006 —
Dallas Diabetes and Endocrine Center Dallas Texas 75230 —
Baylor Endocrine Center Dallas Texas 75246 —
University of Texas Southwestern Medical Center Dallas Texas 75390-8858 —
Jacon Medical Research Associates, LLC Houston Texas 77030 —
JVC Family Medicine Houston Texas 77040 —
Clinical Trial Network Houston Texas 77074 —
Endocrine and Psychiastry Center Houston Texas 77095 —
Pioneer Research Solutions, Inc. Houston Texas 77099 —
Midland Clinical Research Center Midland Texas 79707 —
Hill Country Medical Associates New Braunfels Texas 78130 —
Naidu Clinic Odessa Texas 79761 —
The Methodist Hospital d/b/a HMRI CCAT at Pearland Pearland Texas 77584 —
Village Health Partners Plano Texas 75024 —
Sun Research Institute San Antonio Texas 78215 —
Northeast Clinical Research of San Antonio, LLC Schertz Texas 78154 —
Kenneth Otah and Associates Sugar Land Texas 77478 —
PHS Clinical Trials Midvale Utah 84047 —
Highland Clinical Research Salt Lake City Utah 84124 —
Burke Internal Medicine and Research Burke Virginia 22015 —
Ettrick Health Center Ettrick Virginia 23803 —
Manassas Clinical Research Center Manassas Virginia 20110 —
Clinical Research Partners, LLC Richmond Virginia 23220 —
Richmond Family Practice Richmond Virginia 23220 —
Larry D Stonesifer, MD Inc., PS Federal Way Washington 98003 —
Premier Clinical Research Spokane Washington 99204 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 436 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01243424, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 7, 2020 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01243424 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →